Biotech-Pharma Federal Updates

MichBio invites executives from Michigan biotech and pharmaceutical companies to join us on Capitol Hill for 2015 BIO Legislative Fly-In. This annual event presents a unique opportunity for MichBio members to meet with Members of Congress and their senior staff on the most important legislative issues facing the biotechnology industry.

There is no registration fee to participate in the BIO Fly-In. However you are responsible for your own travel and lodging costs. Visit www.bio.org to register for the Fly-In. You will notice that no hotel block is listed… more details are forthcoming.

MichBio Opposes Proposed “Medical Innovation Act”

Sen. Elizabeth Warren (D-MA) plans to introduce “The Medical Innovation Act,” a proposal that would provide increased funding to NIH with the pharmaceutical industry to pay for this initiative.

The bill seeks to impose an “innovation fee” on any company that has entered into a settlement agreement with the Department of Justice, has at least one blockbuster drug, and in some way can be linked to NIH-funded research. In actuality this would be an “innovation tax” – harming medical innovation and the patients that rely on it.

Besides, there are many legitimate reasons for settlement agreements that do not necessarily imply an admission of guilt, any illegal activity or operation in bad faith. Companies shouldn’t be penalized because of the act of settling with the government.

MichBio has written to both Sens. Stabenow and Peters asking that they strongly consider not signing on to the Medical Innovation Act legislation. We’ll keep you updated.

Guidance Issued on Pharma Product Tracing

FDA announced the availability of a guidance for industry entitled, “DSCSA (Drug Supply Chain Security Act) Implementation: Product Tracing Requirements – Compliance Policy.” This final guidance document is intended for trading partners (i.e., manufacturers, wholesale distributors, and repackagers), and addresses the readiness of the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the exchange of product tracing information, as well as conveys the Agency’s intended enforcement under section 582. This enforcement discretion aims to avoid possible disruptions in the prescription drug supply chain as the new requirements come into effect.